FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Hemostasis Probe, Model: CD-B622LA
- Recall number
- Z-1481-2024
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Hemostasis Probe, Model: CD-B622LA
- Status
- Open, Classified
- Initiated
- 2024-01-05
- Posted
- 2024-04-05
- Terminated
- not on file
- Reason
- The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
- Root cause
- Employee error
- Action
- On January 30, 2024, the firm notified its only customer of the issue via URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION letters. Actions to be taken by the end user: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact your Regional Customer Service, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number "XXXX and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including mispackaging, to your Regional Complaint Intake Contact. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact your regional contact person.
- Quantity
- 36 units (all OUS)
- Distribution
- International distribution only.
- Lot, serial or model codes
- Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212
- 510(k) numbers
- ["K123319"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28